KR20150120879A - 2D and 3D Flat Braid Embolic Implant With Enhanced Aneurysm Neck Coverage - Google Patents

Abstract

A block apparatus for blocking a target area comprises a slender member having first and second side edges vertically extended along the slender member, and a member width. The member may have a folded structure where the first and second side edges are rolled toward each other around a vertical axis of the member. Also, the member has an expanded structure including loops in series, and having the first and second sides unwound to be separated from each other.

Description

2D and 3D Flat Braid Embolic Implant with Enhanced Aneurysm Neck Coverage of Enhanced Aneurysm Neck Coverage.

The present disclosure relates to an implantable device. More particularly, the present disclosure relates to an occlusion device for intravenous implantation and, in some embodiments, for the treatment of aneurysms.

A number of embolization devices have been provided for the treatment of aneurysms. Generally, the braided-ball embolization devices, coils, and other types for embolization operate through blood flow cleavage and subsequent thrombus formation. Currently, aneurysms are treated with embolization coils such as Covidien Axium ^™ or Stryker GDC® 10. These embolization devices are small coils having an outer diameter in the range of 0.0090 inches to 0.0145 inches. These devices are heat treated on the mandrel to give a suitable two- or three-dimensional shape for the aneurysmal shape.

At least one aspect of the present disclosure provides a method and apparatus for delivering occlusion devices or devices (e.g., stents or stents) within a body. The occluding device can be easily matched to the shape of the curved vasculature of the vasculature structure. Closure devices can be used for a variety of applications. By way of example, in some embodiments, the occlusion device directs blood flow in the vasculature such that it substantially or completely blocks the neck of the aneurysm or away from the aneurysm by substantially or completely disrupting blood flow within the aneurysm. In addition, the embodiments of the occlusion devices disclosed herein provide a single device with various advantages that were previously possible only by using a combination of various medical devices.

According to some embodiments, an apparatus is disclosed that is capable of having a flattened profile formed from a tubular material or a flat sheet. The device may be heat treated to impart a two- or three-dimensional shape.

The device may be formed from a polymer, a metal, or a combination of a polymer and a metal. The device can be braided, knitted or woven into multiple filaments within a single stitch or carrier. Radiopaque filaments may be added to improve visibility during and after delivery to the target vasculature structure. Embodiments of the device may have wider contours than the coils and thus require fewer devices to achieve proper aneurysm neck coverage and aneurysmal blood flow arrest. In addition, the device can provide an excellent frame-shaped support of the aneurysm sac.

According to some embodiments, a method of delivering one or more devices includes shaping the device into a cylindrical or "helical" shape and delivering the device through a catheter. The step of shaping the device into a cylindrical or spiral shape can minimize the crossing profile and allow access to distal dissection structures. Thus, some embodiments may be used for smaller vascular structures than are possible for a typical stent or other such expandable structure. It also improves the propulsion of the device by reducing the propulsion resistance of the device.

The techniques of the present invention are illustrated by way of example, in accordance with various aspects described below. Various embodiments of aspects of the techniques of the present invention are conveniently described in numbered clauses or embodiments (1, 2, 3, etc.). These are provided by way of example and do not limit the technique of the present invention. Any dependent clause may be combined in any combination with each other or with one or more other independent clauses to form an independent clause. Other provisions may be provided in a similar manner. The following is a non-limiting summary of some embodiments presented herein.

Clause 1. An occlusion device for occluding a target area, the elongate member comprising opposing first and second side edges extending longitudinally along the member, Said member comprising: (i) a folded structure in which first and second side edges are curled toward each other about a longitudinal axis of said member, (ii) said member forming a series of loops, The closure device has an expanded structure that is curled so that the edges are spaced apart from each other.

Clause 2. In clause 1, the first and second side edges are unfolded to be spaced apart from each other by no more than twice the width of the member.

Item 3. The closure device of clause 2, wherein the first and second side edges are curled to be spaced apart from each other by approximately a member width.

Item 4. The closure device according to any one of the preceding clauses, wherein the elongate member comprises a shape memory material.

5. In an enclosure according to clause 4, the elongate member comprises a material that is in austenitic state when in an expanded configuration.

Clause 6. The closure device according to any of the preceding clauses, wherein the elongate member comprises a flattened tubular member.

7. The closure device according to any one of the preceding claims, wherein the member comprises a plurality of filaments.

Clause 8. The closure device according to clause 7, wherein the spacing of the filaments varies along the length of the member.

Item 9. The closure device according to item 7, wherein the plurality of filaments are braided together.

10. In clause 7, the plurality of filaments are weaved together.

Item 11. The closure device according to item 7, wherein the member is configured so that the filament forms a flat tubular member.

Item 12. The closure device according to item 11, wherein the filament of the tubular member has a variable pitch.

Item 13. The closure device according to any of the preceding clauses, wherein the elongate member comprises at least one slit.

Item 14. The closure device according to item 13, wherein at least one slit extends along the longitudinal axis of the member.

Item 15. The closure device of clause 13, wherein the elongate member includes a plurality of slits extending along the longitudinal axis of the member and spaced apart in a substantially linear configuration.

16. The closure device according to any of the preceding clauses, wherein the first and second side edges comprise a plurality of wing elements extending laterally therefrom.

Item 17. The closure device of clause 16, wherein the wing element extends from opposite sides of the elongate member.

Item 18. The closure device of clause 17, wherein the pair of wing elements extend from opposite sides in a first longitudinal position along the member.

Item 19. The method of clause 17, wherein the wing element comprises a first and a second set of wing elements, the first set extending from a first side of the member and the second set extending in a longitudinal direction different from the first set Wherein the second side of the member extends from the second side of the member.

20. An occlusion device for occluding a target area comprising a elongate member comprising a plurality of filaments, the member having a plurality of wing elements extending from a central backbone and a backbone, the member comprising: (i) A folded structure that is curled toward the backbone about a longitudinal axis of the member; and (ii) an extended structure in which the backbone forms a series of loops.

Item 21. The closure device of clause 20, wherein the wing element extends from opposite sides of the elongate member.

22. In Clause 20 or 21, the wing element comprises first and second sets of wing elements, the first set extending from the first side of the member and the second set being different from the first set And extends from a second side of the member in a longitudinal position.

23. An occlusion device according to any one of claims 20 to 22, wherein the elongate member comprises a flat, braided tubular member.

24. The closure device according to any one of clauses 20-23, wherein the wings are unfolded in a direction away from the backbone in an expanded configuration.

25. A method of operating an occlusion device assembly, comprising advancing a elongate member of a folded configuration within a catheter, the member including opposing first and second side edges extending longitudinally along the member Wherein the first and second side edges are curled toward each other about a longitudinal axis of the member in a folded configuration; and a second step of moving the member across the catheter distal end to release the member into the expanded configuration, Wherein the first and second side edges are moved away from each other in an expanded configuration, and wherein the member is rolled into a series of loops.

Item 26. The method of clause 25, further comprising positioning a distal end of the catheter in an orifice of an aneurysm, wherein the compressing step comprises compressing the member into the base of the aneurysm.

Additional features and advantages of the techniques of the present invention are set forth in the following description, may be apparent from the following detailed description, or may be learned by practice of the invention. The advantages of the techniques of the present invention will be realized and attained by the detailed description set forth and the structures particularly pointed out in the examples and the accompanying drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention technology.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are included to provide a further understanding of the technology and which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention do.
1 is a side cross-sectional view illustrating the deployment of an apparatus into an aneurysm, in accordance with some embodiments.
2A is a perspective view of an occlusion device that may be released in a target area of a body conduit, in accordance with some embodiments.
Figure 2B is a cross-sectional perspective view of an apparatus according to some embodiments, along its longitudinal axis, and the apparatus is a first expanded structure that may be achieved upon expansion in a target area.
FIG. 2C is a cross-sectional perspective view along the longitudinal axis of the apparatus according to some embodiments, wherein the apparatus is a second folded structure that can be maintained during advancement to the target area.
Figures 3A-3I illustrate aspects and optional features that may be incorporated within a device, in accordance with some embodiments.
Figure 4 illustrates a device of a folded configuration within a catheter according to some embodiments.
Figures 5A-6B illustrate cross-sectional views of a device disposed within a catheter, in accordance with some embodiments.
Figures 7A-7F illustrate incremental steps of deployment of an apparatus into an aneurysm, in accordance with some embodiments.
Figure 8 illustrates a range application to the neck of an aneurysm using one or more devices, in accordance with some embodiments.
Figures 9A and 9B illustrate additional features of an apparatus of an expanded configuration according to some embodiments.

In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the techniques of the present invention. It should be understood that the techniques of the present invention may be practiced without some of these specific details. In other instances, well-known structures and techniques are not shown in detail in order not to obscure the teachings of the present invention.

It is also to be understood that the description sets forth specific details of various embodiments, which description is illustrative only and is not to be construed in any way as limiting. Additionally, although certain embodiments of the present invention may be disclosed or illustrated with respect to aneurysm treatment, such an embodiment is contemplated as being capable of being used in the treatment of other obstructions within the vasculature. In addition, various embodiments of some embodiments and variations thereof that can be devised by those skilled in the art are included in the generic concept described herein.

According to aspects of some embodiments disclosed herein, an occlusion device and method of use are provided that provide advantages over conventional coil, stent, or braided structures, either alone or in combination, for an aneurysm occlusion. Some embodiments may provide larger aneurysm surface contact than conventional coils, which tend to increase the surface area of the implanted occlusion device, resulting in increased thrombosis, while allowing for the use of less device material . The possibility of aneurysm redissociation can be greatly reduced through some embodiments that can provide good wall juxtaposition and neck coverage. In addition, some embodiments may be easier to operate within an aneurysm dome or cavity. By way of example, the device can more easily match the internal shape of the aneurysm cavity. In addition, when the aneurysm begins to decrease in size, aspects of some embodiments allow the device to be deformed such that the device is compressed or sized to promote healing of the aneurysm, which is generally accomplished using conventional coils or other devices It is not possible.

By way of example, Figure 1 is a side cross-sectional view illustrating the deployment of an apparatus into an aneurysm according to some embodiments. As shown, the device 10 may be advanced to the target aneurysm 40 using the device assembly 20. The device 10 may be advanced from the catheter 22 of the assembly 20 to the base 44 of the aneurysm 40 through the neck 42 of the aneurysm 40.

The device 10 may include a body 12 that may have a elongated shape. In some embodiments, the body 12 can be deployed in a first configuration when deployed within the catheter 22 and expanded into a second configuration when released from the catheter 22 to the aneurysm 40. For example, in some embodiments, the first configuration may be achieved when the body 12 is constrained within the catheter 22 and is primarily curled or rolled transversely to the longitudinal axis of the body 12. In some embodiments, the second configuration may be achieved when the body 12 is released from the catheter 22 and is curled or rolled in a direction primarily along the longitudinal axis of the body 12. Thus, when the body 12 of the device 10 is released from the catheter 22, the primary curl or wrap of the device 10 is transferred from one direction along the longitudinal axis to the other, Into a rounded, rounded shape within the aneurysm 40. When the device 10 is released, the body 12 is incrementally more in contact with the aneurysm wall and more portions of the neck 42 of the aneurysm 40 are removed until the neck 42 is substantially covered or blocked. . As a result, whether the single device is inserted into the aneurysm 40 or multiple devices, the wall of the aneurysm is completely contacted by the device (s), and the volume of the aneurysm 40 is substantially packed or filled, The circulation or fluid movement in the aneurysm 40 through the neck 42 is substantially slowed or stopped.

2A shows an embodiment of an occlusion device 100 that can be released into a target area of the body to occlude a target area. The target region may be a body conduit or cavity, such as an aneurysm, including a neurovascular or intracranial aneurysm, a blood vessel or other hollow anatomy. According to some embodiments, the device 100 may provide a number of distinct advantages over other occlusion devices, such as coils and expandable filament structures, including stents, wire cages, and other known occlusion devices.

By way of example, in the case of an aneurysm treatment, the device 100 may pack or fill a target volume and accommodate the shape of the target volume, and such function may not perform the stent or braided structure itself properly. In addition, the device 100 may contact irregular sidewall shapes of the aneurysm. In addition, device 100 can maximize coverage of the aneurysm neck, properly grasp the sidewall of the aneurysm to prevent device escape or slipping, facilitate the aneurysm neck to achieve different healing responses, And these results can be achieved without the need for other frame forming or throttling devices, and this function may not be able to perform the coil structure itself properly.

Referring to FIG. 3A, the apparatus 100 is illustrated as including a body, ribbon, or elongate member 150 formed of a braid having a plurality of strands, such as metallic wires or polymer filaments. By way of example, body 150 may include nitinol or other suitable (superelastic) material. By way of example, and in accordance with some embodiments, the materials that make up the body 150 may be configured such that at or near room temperature the body 150 is substantially straight (and, for example, relatively elongated in the second structure for delivery) And may be dried at body temperature or near human body temperature (and relatively shortened or looped in a first configuration for space packing or filling in the target area). However, in some embodiments, the apparatus 100 may also include other types of materials or material configurations. By way of example, the device 100 may comprise a bioabsorbable material or polymer. The material may also include cobalt chromium.

In addition, the apparatus 100 may comprise a single continuous material or molded member of a woven, knitted, braided or unbraided, unknitted and non-woven state, whether flat sheet or tubular. The apparatus 100 may comprise a single layer or multi-layer sheet or tubular structure. In some embodiments, the apparatus 100 may comprise a laser cut or an optoelectronic material. The device 100 may also include a material formed of long fibers that are pressed together or otherwise joined together in one or more non-woven fibers, for example, a tubular or flat sheet structure.

In some embodiments, the apparatus 100 may be constructed as a tubular structure, which may be planarized to provide a generally flat cross-sectional profile. Planarizing the tubular structure can thus provide a multilayer sheet or structure in which the layers are accidentally connected along the side longitudinal edges of the device.

In some embodiments, the apparatus 100 may comprise a flat sheet, which may fold itself over one or more times along the longitudinal axis of the apparatus 100. [ Thus, folding of the material can provide a multilayer sheet or structure. The use of such a material sheet facilitates manufacturing and allows for greater control of the ends of the device 100.

In some embodiments, regardless of the material or configuration of the device 100, the device 100 may include a textured surface or a body having a smooth surface. By way of example, in some embodiments, the apparatus may comprise a body having an irregular, porous, dimpled, braided, woven or knit surface. Accordingly, some embodiments of the device 100 may be configured to provide voids, openings, indentations, or interstitial space, which impart a desired level of thrombosis and / or resistance to blood flow. In addition, such pores, openings, indentations, or interstitial spaces may advantageously engage the sidewall of the aneurysm while being released into the aneurysm. For this reason, during deployment of the device 100, the textured surface enhances wall juxtaposition and can ensure that the device 100 is not associated with the aneurysm wall and does not move within the aneurysm and escape from the aneurysm.

Also, instead of or in addition to this textured surface, a thrombogenic material such as gold, platinum, platinum-iridium alloy or fibrin can be used in the device 100 as a coating, additive or otherwise. When a braid is used, the braid wire metal may be selected to maximize the electrical flow (and any consequent thrombosis).

In use, the device 100 shown in FIG. 2A is mounted on a delivery system, such as a catheter, and can be delivered to a target area within the body. According to some embodiments, when released from the delivery system in the target area, the apparatus 100 may take an extended first or primary structure 110 as shown in FIGS. 2A and 2B. However, when the device 100 is delivered to the target area, it may also have a folded second or secondary structure 120 as shown in the embodiment of FIG. 2C. Thus, to facilitate delivery of the device 100, the body 150 may be positioned in a structure such as the folded structure 120 when in the delivery catheter. When released from the delivery catheter, the body 150 may preferentially take on the expanded structure 110. Thus, in the unconstrained state, body 150 may tend to self-adjust or move into expanded structure 110 (as opposed to moving into folded structure 120 or folded structure).

2A and 2B, the body 150 of the device 100 is looped, bent, curled, or rolled around an axis transverse to the longitudinal axis 160 of the body 150. In the illustrated embodiment, Can be achieved. The body 150 of the device 100 may also be positioned in the folded configuration 120 shown in Figure 2C (e.g., when the device 100 is within the catheter) Looping, bending, curling, or winding about an axis aligned with the axis of rotation.

In some embodiments, body 150 can be geometrically defined using "excellence" as the direction or resultant vector indicated by the thumb when the fingers of the hand are oriented along the same arc of body 150 Quot; curling vector "162 < / RTI > 2B, in the expanded structure 110, the curl 162 may be oriented substantially transversely with respect to the longitudinal axis 160 of the body. In some embodiments, the curl vector 162 may extend in a generally vertical direction relative to the longitudinal axis 160 when the body 150 is in the extended configuration 110. In some embodiments,

By way of example, body 150 may include opposing first and second side edges 172, 174. In the expanded structure 110, at a given point along the longitudinal axis 160, the first and second edges 172, 174 may be spaced a first distance. In addition, as shown in FIG. 2B, the apparatus 100 may include a leading edge 176 (which may represent a cross-section of the device substantially perpendicular to the longitudinal axis 160) And may have a substantially flat cross-sectional shape as opposed to the expanded structure 110. FIG.

The device 100 may substantially pack or fill the internal volume of the body conduit, such as an aneurysm, after being released from the delivery system. By way of example, and as further described below, when the apparatus 100 is in the expanded structure 110, the apparatus 100 may be configured as a non-spherical shape, including a spherical or hemispherical shape, a noodle, a coil, (E.g., a toric, cone, cylinder, or other shape rotated about a central point or a co-planar axis), and / or combinations thereof, can do. By way of example, FIG. 2A illustrates one embodiment of a device having a bulbous or substantially spherical configuration, and FIGS. 9A and 9B illustrate an embodiment of a device 100 having a semi-cylindrical, 3-D or cylindrical configuration .

However, in the folded structure 120 illustrated in FIG. 2C, the body 150 may have a substantially cylindrical configuration. By way of example, body 150 may be curved, curled, or wrapped about or about a line substantially parallel to longitudinal axis 160. The body 150 may be curled so that the curling vectors 162 may be oriented substantially parallel to the longitudinal axis 160 of the body, as shown in FIG. 2C. Although the curvature vector 162 may not be substantially parallel to the longitudinal axis 160 when the main body 150 is in the folded structure 120, the curvature vector 162 is approximately parallel to the longitudinal axis 160 Less than 30 degrees, less than about 20 degrees, or less than about 10 degrees. Also, in the folded structure 120, the first and second side edges 172, 174 may be curled toward each other.

By way of example, and as noted above, at a given point along the longitudinal axis 160, in the expanded structure 110, the first and second side edges 172, 174 may be spaced a first distance. The first and second side edges 172,174 may be spaced a second distance less than the first distance at a given point along the longitudinal axis 160 when moving to the folded structure 120. [ In addition, as shown in FIG. 2C, the leading edge 176 of device 100 (which may represent a cross-section of the device substantially perpendicular to the longitudinal axis 160) 110 < / RTI >

In some embodiments, the first and second side edges 172, 174 may be substantially parallel to one another in the folded structure 120. By way of example, the first and second side edges 172, 174 may extend substantially parallel to the longitudinal axis 160. In some embodiments, the first and second side edges 172, 174 may also extend spirally at least partially about the longitudinal axis 160 in the folded structure 120.

Although the first and second side edges 172 and 174 pass through the curvature of the vasculature structure, while the device 100 is being rolled or wound about the longitudinal axis 160 in the folded configuration 120, Bend or bend slightly onto the longitudinal axis 160. [0035] For purposes of this disclosure, such movement is considered to be conventional during the advancement of the device 100 to the target area, and when the device 100 is positioned in the folded second structure 120 in the catheter, the device 100 Are considered to be in the folded structure 120 regardless of the degree or amount of flexure or looping of the device 100 onto the longitudinal axis 160.

Advantageously, at this time, some embodiments can provide a device that is flexible enough to bend or deflect while advancing through the curves of the vasculature, without twisting or breaking the fibers or filaments of the device. In addition, some embodiments also allow the device 100 to receive substantial thrust without folding or buckling. By way of example, some embodiments allow the device to be positioned in a generally tubular or curled configuration, thus beneficially increasing the strength of the device when under axial compression in a folded configuration.

As described above, according to some embodiments, the body 150 of the apparatus 100 may be configured with at least one predetermined structure. By way of example, the body 150 of the apparatus 100 may be deflected such that the apparatus 100 takes a first predetermined two-dimensional or three-dimensional structure in the expanded structure 110. [ However, in some embodiments, the body 150 of the apparatus 100 may also include a second predetermined structure in which the apparatus 100 takes a folded structure 120. [

In some embodiments, the body 150 of the device 100 may be deflected toward one or both of the first or second predetermined structures. Apparatus 100 may also be preset to take a first structure as a primary structure and a second structure as a secondary structure. By way of example, the body 150 of the apparatus 100 may have a bi-stable position. Optionally, a first structure may be preferred when no external force is exerted on the body 150.

In addition, some embodiments may be provided in which the device has only one or both of these predetermined structures. By way of example, in some embodiments, device 100 can be mounted and deployed within a catheter, although body 150 of device 100 may have only a predetermined expanded structure 110 It can be rolled or dried enough to make it. It should also be appreciated that in some embodiments the device 100 may provide a two or three dimensional shape to the device 100 although the body 150 of the device 100 may have only a predetermined folded structure 120 May cooperate with other structures, such as the tension members described below.

Figures 3a-3i illustrate top views of various embodiments of an occlusion device in a planar or planar configuration for illustrative purposes. Any of the devices illustrated in Figures 3A-3I may be formed using a tubular mesh material planarized into a two-layer sheet. However, any of the devices illustrated in Figs. 3A-3I may also be comprised of a single layer sheet of cellular material that is folded or unfolded once, twice, or more times at the time of device formation. Cross sectional profiles of some embodiments are illustrated in Figures 5A-6B. Also, according to some embodiments, the device may be configured to increase the coverage of the device in its expanded configuration, or to facilitate access through the device, whether formed as a flattened tubular mesh or a single layer sheet (folded or unfolded) Such as slits or protrusions, that can be used to create the desired shape. Other features may also optionally be included in the device to provide other features, such as radiation-impermeable, drug delivery means, inflatable materials, or those described herein or known in the art.

3A illustrates an embodiment in which the body 150 is configured such that the first and second edges 172 and 174 are substantially straight or extend substantially parallel to the longitudinal axis 160 of the device 100. For example, The cross section of the substrate 100 is illustrated.

FIG. 3B illustrates that the device 100 may optionally include at least one longitudinal slit. As shown, the apparatus 100 may include at least one slit 190 extending along a longitudinal axis 160 of the apparatus 100. In some embodiments, the apparatus 100 may include a plurality of slits 190 as shown in FIG. 3B. The slit 190 allows the physician to advance or inject another embolization device, embolic material, or liquid, such as one or more coils into the aneurysm. As an example, a suitable liquid embolization is the Onyx ^TM liquid embolization system manufactured by Covidien LP of Irving, CA. The Onyx ^TM liquid embolization system is a non-adhesive liquid used in the treatment of cerebral arteriovenous malformation. The Onyx ^TM liquid embolization system consists of an ethylene vinyl alcohol ("EVOH") copolymer dissolved in dimethylsulfoxide ("DMSO") and suspended microtintal powder to provide contrast for visualization under fluoroscopy. Other liquid embolization solutions are also contemplated.

3C illustrates, in some embodiments, that the apparatus 100 may optionally include a feature, structure, or tension member 194. In some embodiments, The body 150 may be formed separately from the tension member 194 so that the tension member 194 acts as a separate and independent component that affects the shape of the body 150. [ As shown in Figure 3c, the tension members 194 can be interwoven with braids.

The tension member 194 may be coupled to one or more sections of the device 100 to provide retention or stretch-resistant properties to the device 100. Thus, in some embodiments, the integration of the tension member 194 may be performed during the expansion of the device 100 in the target area and through the delivery system (not shown) through the delivery system, although the device 100 may be formed of an elastic or deformable material 100 can be guaranteed that the length of the device 100 is substantially unchanged or only slightly changed. Also, in some embodiments, the tension member 194 can elastically provide endurance. Thus, the length of the device 100 can increase, and the tension member 194 can withstand stretching and can push the device 100 toward its non-elongate original length.

In some embodiments, the tension member 194 may provide a two-dimensional or three-dimensional structure to the device 100 when it is in the expanded structure 110, as well as providing an anti-stretch function. The tension member 194 may be used to impart any suitable one of the two- or three-dimensional structures described herein or any other such suitable structure.

The desired unconstrained structure can be treated by heat setting or otherwise in tension member 194. The tension member 194 may be used with the device 100 without the device itself or with a specific untreated structure in any particular heat treatment setting or otherwise, or with the device 100 having a pre-established two-dimensional or three-dimensional structure. When the tensile member 194 only has a predetermined unrestrained structure, the tension member 194 urges the device 100 in a two-dimensional or three-dimensional unconstrained or semi-constrained configuration, can do. The non-constrained structure thus achieved by the apparatus 100 may be similar to a non-constrained structure that is generally predetermined for the tension member 194.

The tension member 194 may include first and second ends, and at least one of the ends is coupled to the body 150 of the apparatus 100. In some embodiments, the tension member 194 may include first and second ends, each of which is coupled to each of the first and second portions of the device 100. The first and second portions of the device 100 may include first and second end portions.

The tension member 194 may assist in the delivery of the device 100 by providing either traction or propulsion during advancement of the device 100. [ By way of example, in some embodiments, the tension member 194 may be coupled to the end or only one portion of the device 100 at one end. In this embodiment, the other end of the tension member 194 may be coupled or gripped to a portion of the delivery system to provide an anti-stretch characteristic. For this reason, the device 100 may be delivered within the catheter using a core wire or assembly comprising a pad or an engagement member at its distal end. The coupling member of the core wire may be coupled to the device 100 at a point remote from the proximal end of the device 100. [ In some embodiments, the mating member may be coupled to the device 100 at a point proximate the distal end of the device 100, such as a midpoint or midpoint along the longitudinal axis of the device 100, have. The tension member 194 is coupled to the proximal end of the device 100 and extends in a distal direction such that the distal end of the tension member 194 can engage a portion of the core wire, In some embodiments, the distal end of the tension member 194 may be frictionally engaged between the engagement member and the device 100, or releasably engaged with the core wire in an alternative manner. Further, in some embodiments, the tension member 194 may be attached to the distal end of the coupling member or core wire and the proximal end of the device 100, and configured to disengage upon release of the device 100 within the target area .

Alternatively, according to some embodiments, the tension member 194 may provide column strength to the device 100. [ The tension member 194 can be used to urge the device 100 in a distal direction through the catheter during delivery of the device 100 by manually pushing the proximal extension of the tension member 194 in the distal direction. By way of example, the tension member 194 may be coupled to the distal end portion of the body 150 of the device 100 and the proximal end of the tension member 194 may be configured to urge the device 100 in a distal direction through the catheter catheter (And, in some embodiments, with the proximal end of the body 150). For this reason, some embodiments of the delivery system may be configured to contact or engage the proximal end of the tension member 194 to propel the device 100 through the catheter.

Additionally, similar to the body 150 of the apparatus 100, the tension member 194, which may be formed separately from the body 150, may include one or more nitinol wires that may be preformed as described above . As an example, Nitinol or AUSTENITIC Nitinol (or other materials) may be used, which is substantially linear (and relatively elongated) at or near room temperature and coil-like at or near human body temperature. Such a tensile member can be used to allow or permit movement from the folded structure 120 to the expanded structure 110 while maintaining the axial length of the device 100 during delivery through the catheter conduit as described above . Also, as described above, some embodiments may be provided in which the tension member 194 imparts a two-dimensional or three-dimensional shape to the device 100 upon release from the catheter.

Referring now to Figures 3D-3E, the body 150 of the apparatus 100 may be configured such that the edges 172,174 converge or diverge relative to each other. 3D, body 150 may include one or more enlarged portions, which may include wings extending laterally outwardly from longitudinal axis 160 of body 150, .

FIG. 3D illustrates a plurality of enlarged portions 200 that extend generally symmetrically from opposite sides of the device 100. 3E also illustrates another embodiment of an apparatus 100 in which a portion 200 enlarged in a staggered configuration extends from opposite sides of the apparatus 100. As shown in FIG. Figure 3g also illustrates another embodiment in which the enlarged portion 200 has different widths or sizes.

The shape and dimensions of the enlarged portion 200 may provide an enlarged portion 200 having a rounded, semicircular edge as illustrated. However, the enlarged portion or wing 200 may also be configured such that the edges 172, 174 have a sinusoidal shape. The enlarged portion may include any shape, size, or occupy any position along the length of the device, and may include any combination of these.

The enlarged portion 200 may be formed with a single continuous piece of material together with the body 150. The body 150 may be cut or otherwise shaped to include the enlarged portion 200. By way of example, body 150 may be formed from a braided sheet or tube whose filaments are laterally elongated and heat treated to form enlarged portion 200. However, in some embodiments, the enlarged portion 200 may be separately formed from the body 150 and subsequently coupled to the body.

The enlarged portion 200 may also be configured to wind or roll about the longitudinal axis 160 or to self extend laterally from the compressed structure. The embodiment illustrated in Figures 3D and 3E illustrates an enlarged portion 200 that can be curled or rolled. 3f and 3g also illustrate an embodiment of the device 100 in which the enlarged portion 200 is in compressed and expanded locations 210 and 212, respectively. At compression or prior to contact with a fluid or heat, the enlarged portion 200 may be a pic count (i. E., The number of filament intersections per inch or < RTI ID = 0.0 & Per-inch (PPI)) or fiber density can be made higher. When released or exposed to fluid or heat, the enlarged portion 200 may move from the compressed position 210 to the extended position 212 as shown in Figures 3F and 3G. By way of example, in some embodiments, the enlarged portion 200 may be superelastic.

As an example, when the enlarged portion 200 is released (such as by de-curling, depressing, or by extension from the folded position), the edges 172, 174 along the extended portion 200 are removed from the body 150 174 < / RTI > along the edges < RTI ID = 0.0 > Edges 172 and 174 may have a maximum width (e.g., measured at distance 220 in Figure 3g) and a minimum width (e.g., measured at distance 222 in Figure 3g). The maximum width 220 may be greater than the minimum width 222. In some embodiments, the maximum width 220 is greater than about 1.1 to about 4 times greater than the minimum width 222, greater than about 1.5 times to about 3.5 times, greater than about 2 times to about 3 times, 2.8 times larger. In some embodiments, the maximum width 220 may not exceed 3 or 4 times the minimum width 222.

3G, the enlarged portion or wing 200 may include a width 224 that is approximately the same as the minimum width 222. In some embodiments, Also, and in some embodiments, the width 224 of the enlarged portion or wing 200 is between about 0.25 times and about 2 times, about 0.5 times to about 1.5 times, about 1 time, About 1.25 times.

Depending on some embodiments, the enlarged portion 200 may be configured to have different widths, sizes (e.g., longitudinal lengths), or shapes along the length of the device 100. Thus, upon release, edges 172 and 174 can form a generally irregular pattern. The maximum and minimum widths 220 and 222 may be in the same range as those described above.

In addition, upon release, the enlarged portion 200 may be configured to provide substantially the same fiber density or pattern as the fiber density or pattern of the body 150. However, the enlarged portion 200 may also be configured to provide a lower fiber density or other pattern than a portion of the body 150 disposed adjacent each enlarged portion or wing 200. In some embodiments, the enlarged portion 200 may be heat treated or otherwise preformed into such a structure.

As discussed above, the enlarged portion 200 can be formed by stretching the body 150 to engage a separate component to the body 150 or to extend it in a discontinuous position along its length. In embodiments where the enlarged portion 200 moves between the compressed and expanded positions, the enlarged portion 200 may help maintain the compressed position until the coating is dissolved in the presence of fluid after release By the use of a coating on the device 100 or by the action of a compressive force.

Referring now to FIG. 3H, according to some embodiments, body 150 may include first and second sections 240, 242 that may have different characteristics. By way of example, the body 150 may be configured such that the braid, woven or knitted pattern changes at least once more or along the length of the body 150. In some embodiments, body 150 may include a braided structure including first and second sections 240, 242. In some embodiments, The first and second sections 240, 242 may have different properties, pick count, filament pitch, filament size or braid / weave / knitted density. Thus, the first and second sections 240, 242 may have different characteristics, which may allow the device 100 to perform advantageously during transfer to the target area and within the target area.

For example, a higher pick count or blade density may tend to reduce or block flow through the device 100, and a lower pick count or blade density may be indicative of a flow of embolic material or coil through the device 100 Or injection. Additionally, the pick count or blade density may also affect frictional engagement with the target area wall and endothelialization upon release from the neck of the aneurysm, for example. In addition, the pitch or alignment of the filaments may affect propelling or longitudinal compressibility when pushing the device 100 in the distal direction within the catheter toward the target area. By way of example, the fibers may be axially aligned with respect to the longitudinal axis of the apparatus 100, thus improving or increasing the propulsive properties of the apparatus 100. In addition, the lower pick count may also tend to increase the propulsive properties of the device 100.

3i, the device 100 may also be configured such that at least one of the proximal and distal ends 250, 252 of the device 100 includes non-traumatic features or components. By way of example, the device 100 includes one or more tips or edges (whether round or rounded) with the proximal and / or distal ends 250, 252 extending therefrom. The filament 260 allows the proximal and / or distal ends 250, 252 to contact moderately and non-traumatically with the target area wall (such as the aneurysm wall). In some embodiments, the filament 260 may include a tip 262 that is round or ball shaped.

Figures 4 to 6B illustrate a view of a device assembly 300 in which the device 100 is disposed within the catheter 302. As shown, the device 100 is a folded structure 120. In the illustrated embodiment, the apparatus 100 includes an enlarged portion 200 that is folded or curled about the longitudinal axis of the apparatus 100. In the illustrated embodiment, The device 100 also includes non-traumatic portions or filaments 260. Thus, the device 100 can be propelled outwardly into the catheter 302 and into the target aneurysm, where the device 100 can extend from the folded structure 120 to an expanded configuration .

Additionally, in accordance with some embodiments, the apparatus 100 may include a radiopaque marker on one or both of its ends, along a length along its length, or along its entire length. Such a marker may be configured similar to the filament 260 and / or its round or ball shaped tip 262. By way of example, the filament 260 and / or its rounded or ball-shaped tip 262 may be radiopaque.

The length of the device 100 may be from about 5 mm to about 250 mm. In some embodiments, the length may be from about 7 mm to about 180 mm. Also, the length may be from about 9 mm to about 100 mm. Also, the length can be from about 10 mm to about 50 mm. The length of the device 100 may also be about 25 mm. As described below, a number of devices having multiple lengths and / or configurations may also be used.

In some embodiments, the apparatus may be configured such that the walls of the apparatus 100 comprise a flow-through pore size. The "flow-through pore size" can refer to the average pore size (at least in part of the device) of pores small enough to interfere with fluid exchange through the pores of the section or inhibit fluid exchange.

The device 100 (e. G., At least in the proximal section of the device) is configured such that the pores of the section are aneurysmal through the sidewall to a degree sufficient to cause thrombus formation and healing of the aneurysm when the tubular member is positioned adjacent to and within the aneurysm. Or may have a flow-through section or active section with a flow-advancement pore size when sized to inhibit the flow of blood into the bloodstream.

By way of example, the flow-through pore size can be achieved when the pores in the flow-through or active section have an average pore size of less than about 500 microns when the device (e.g., stent) is in the expanded state. In some embodiments, the average pore size may be less than about 320 microns. Also, the average pore size may be from about 25 microns to about 350 microns. The average pore size may also be from about 40 microns to about 200 microns. Further, in some embodiments, the average pore size may be from about 60 microns to about 150 microns. Also, the average pore size can be about 120 microns.

Approximately within this range, the average pore size can act to direct fluid flow and to induce thrombus formation in the conduit or inner volume surrounded by the wall. The pores may have a substantially constant pore size. The pores may have an average pore size measured using an inscribed circle diameter.

Additionally, in some embodiments, an apparatus 100 having an air gap in the range of 10% to 95% in the expanded braid may be used to achieve these effects. In some embodiments, a porosity of from about 30% to about 90% may be used to achieve these effects. Also, pore sizes ranging from about 50% to about 85% can be used to achieve these effects. Various other features, such as those disclosed in co-pending International Application No. PCT / US13 / 33419, filed March 22, 2013, the contents of which are incorporated herein by reference, may be incorporated into device 100.

5A-5B illustrate cross-sectional views of the device 100 and the catheter 302 taken along the cross-sectional lines 5A-5A and 5B-5B of FIG. Similar to what is illustrated in FIG. 2C, FIGS. 5A and 5B illustrate an embodiment of a device 100 that may be configured to operate around a line 304 that is substantially parallel to the longitudinal axis 160 of the device 100, Or rolled, rolled, rolled, rolled or rolled.

6A and 6B illustrate another embodiment of the device in which the device is folded or compressed from a tubular or sheet structure. By way of example, FIG. 6A includes a tubular shape in which device 100 is planarized and is curved, rolled, or wound about a line 304 that is substantially parallel to longitudinal axis 160 or about line 304 . Figure 6b also shows that device 100 includes a sheet that is wrapped around line 304 that is at least once folded and substantially parallel to longitudinal axis 160, Rolled, rolled or rolled.

According to some embodiments, the device 100 may exhibit improved or higher propulsive properties compared to a device or structure that is comparable by its folded structure 120. The folded structure 120 may improve propellant by reducing the amount of exposed material in contact with the catheter inner wall and / or bringing the folded device into contact with less than the entire circumference of the catheter inner wall.

By way of example, at least a portion of the device 100 does not contact the inner surface or inner wall 310 of the catheter 302 because the device 100 is curved, curled, or rolled in the folded configuration 120. In some embodiments, the inner wall 310 may be contacted along an area of less than its entire circumference. In its folded configuration 120, is merely radially folded or compressed in a different manner from an expanded diameter to a compressed diameter as is typical in other braided structures, such as stents and blade balls The device 100 requires much smaller propulsion than a similar structure (which increases the axial length of the device or the blade density).

By way of example, referring to FIG. 5B, the apparatus 100 may be wound itself such that the internal portion of the cross-section of the apparatus is radially inward of the cross-sectional outer portion of the apparatus. Section internal portion of the device is considered as a wound portion of the device radially superimposed by another portion of the device for purposes of the present disclosure. Because of this, only the outer portion of the cross-section of the device contacts the inner wall 310 of the catheter 302.

In addition, as illustrated in Figures 5A, 6A, and 6B, in some embodiments, the dried device 100 may extend below the entire circumference of the inner wall 310 of the catheter 302. [ As shown, the cross-sectional width of the device 100 may be less than the circumference of the inner wall 310 in its folded or compressed, planarized cross-sectional configuration (which may be taken in an expanded configuration as illustrated in Figure 2b) .

Thus, depending on the size of the catheter used, which can vary from about 3 Fr to about 8 Fr, the device 100 may be flattened or folded, and in some embodiments may be self-wound. The width of the planarized section may be between about 3 mm and about 7 mm, between about 4 mm and about 6 mm, or about 5 mm when the device is not self-wound (e.g., prior to insertion into the catheter) have. These dimensions can be used for single-layer or multi-layer planarized sections.

The device may be formed from a flat sheet. By way of example, when folded into two substantially identical sections prior to being rolled and inserted into the catheter, the flat sheet may have a width between about 6 mm and about 14 mm, between about 8 mm and about 12 mm, or about 10 mm . Similar dimensions can be observed when the device is formed using a folded sheet having a tri-fold cross-section.

When the device is self-wound, the cross-sectional dimensions of the wound planarized material may be between about 1 mm and about 4 mm, between about 1.5 mm and about 3.5 mm, or between about 2 mm and about 3 mm. The cross-sectional diameter of the device also tends to depend upon the performance of the material (e.g., its bending strength) for winding in a delivery tube or catheter when wound on its own

The folded structure 120 of the device 100 thus allows a greater amount of material or device to be advanced through the catheter 302 while minimizing the frictional resistance between the catheter wall 310 and the device 100 . As a result, the propulsive properties of the device 100 are advantageously improved.

In accordance with some embodiments, various delivery methods and systems are also provided. By way of example, one or more devices may be delivered in combination with a catheter using the system disclosed herein. The device delivery system may include a elongate tube or catheter that slidably receives a core assembly configured to deliver the device through the catheter. The catheter may have an opposed distal end that can be located at the proximal end and a treatment site within the patient, an inner conduit extending from the proximal end to the distal end, and an inner surface or wall facing the conduit. At the distal end, the catheter has a distal opening through which the core assembly and / or device is advanced past the distal end to expand, release or deploy the device within the target area, such as a vessel or aneurysm. The proximal end may include a catheter hub. The catheter may form an alternate longitudinal axis A-A extending between the proximal and distal ends. When a delivery system is used, the longitudinal axis need not be linear along some or any portion of its length.

The catheter may optionally include a microcatheter. For example, the catheter may optionally include any of a variety of lengths of MARKSMAN ^TM catheter, available from Covidien LP of Irving, California material. The catheter may optionally include a microcatheter having an inner diameter of about 0.030 inches or less at the distal end and / or an outer diameter of 3 Fr or less. Instead of or in addition to these specifications, the catheter may include a microcatheter configured for percutaneous access to a location within the neurovascular structural end of the internal carotid artery or internal carotid artery using its distal opening.

Additional embodiments of the catheter, as well as additional details and information regarding the components that may optionally be used in the embodiment of the catheter described herein, may be found in a number of publications such as those published on September 29, 2011, entitled " Can be found in U.S. Patent Application Publication No. US 2011/0238041 A1. All of the above publications are incorporated herein by reference and form part of this disclosure.

FIGS. 7A through 7F illustrate aspects of the occlusion device 100 and delivery assembly 300 advanced to the target aneurysm 400. The device 100 may be advanced through the neck 402 of the aneurysm 400 toward the base 404 of the aneurysm 400 as illustrated in Figures 7a and 7b. When the device 100 is advanced into the aneurysmal 400, the device 100 is unwound, depressed, or expanded from its folded configuration to cause the opposite edges of the device to move away from one another, This usually starts to have a flat cross-sectional structure.

As the device 100 continues to advance into the aneurysm 400 as shown in Figs. 7c and 7d, the enlarged portion 200 of the device 100 and the body 150 of the device 100 are positioned within the aneurysm 400 The base 404 or the inner wall of the base plate 404. The device 100 tends to come into frictional contact or engagement with the inner wall of the aneurysm 400 when the enlarged portion 200 and the body 150 are in contact with the inner wall of the aneurysm 400, The ability of the device 100 for free movement and engagement within the aneurysm 400 during initial inflation and entry of the device 100 into the aneurysm 400 Lt; / RTI > Thus, a predetermined length of device 100, which can be about 1/4 to about 3/4 or about 1/3 to about 2/3 or about 1/2 of the length of device 100, is released into the aneurysm 400 The device 100 tends to engage the inner wall of the aneurysm 400. This coupling allows the physician to better predict the dislodged position or deployment characteristics of the device 100 within the aneurysm 400. In addition, this coupling also allows the device 100 to be held more tightly within the aneurysm 400, thereby avoiding the escape of the device 100 from within the aneurysm 400.

Additionally, as illustrated in Figures 7e and 7f, as the device 100 continues to advance into the aneurysm 400, the neck 402 tends to be completely blocked or covered. The wings 200 and the body 150 are positioned between the inner wall of the aneurysm 400 that extends over the neck 402 and the inner wall of the aneurysm 400, There is a tendency to combine. As a result, the volume of the aneurysm 400 can be substantially packed or filled, even if multiple devices are inserted into which the single device is inserted into the aneurysm 400 so that circulation or fluid movement within the aneurysm 400 is slowed Or circulation or fluid movement into the aneurysm 400 through the neck 402 is substantially slowed or stopped. Figure 8 illustrates the device 100 or a plurality of devices viewed from the aneurysm neck 402 into the aneurysm 400 after they are released into the aneurysm 400. The use of an apparatus with an optional but enlarged portion 200 can further improve the coupling of the sidewall of the aneurysm 400 and the coverage of the neck 402.

Referring again to Figure 8, considerable coverage of an aneurysm neck 402 using an apparatus having a textured surface comprising a braided or coated surface such as those described above may be beneficial in inducing and inducing a healing response. Thus, an excellent neck coverage allows easier necking of the neck 402. Thus, in contrast to conventional treatments that require both stents and other frame-forming arrangements and coils to prevent coil escape from within the large neck varices, a single device is used to treat a wide neck aneurysm An embodiment can be provided.

According to some embodiments, the delivery of one or more occlusion devices may be performed by delivering a single occlusion device or multiple occlusion devices. By way of example, the first device may be released into the aneurysm, which may function as the outermost layer of a group of devices deployed into the aneurysm. Subsequent devices can then be inserted into the first frame forming device within the aneurysm. Such additional devices may include finishing coils or additional devices such as those disclosed herein. The size and / or shape of the coil or device that is subsequently released into the aneurysm may be substantially the same or different sizes and / or shapes or may be progressively smaller.

According to one of the advantageous features of some embodiments disclosed herein, when using a coil, one or more devices can be delivered into the aneurysm without the need to use a frame-forming structure to hold the device within the required aneurysm. Also, much better than a coil, the device described herein can provide a good neck coverage. Also, much better than a coil, the device described herein extends reliably and predictably with a predetermined configuration or structure. In addition, in contrast to expandable braid-like structures such as stent or braided ball, the device described herein can pack or fill a volume of target space, such as an aneurysm, as much as possible in the coil. Accordingly, these and other such advantages, which are heretofore attained only through a number of discrete components, can be achieved using embodiments of the apparatus described herein.

When delivering multiple devices into an aneurysm, the device, in some embodiments, the length of the coil may be between about 1 cm and about 10 cm. The order of delivery of such devices may be in the order of decreasing size. By way of example, a physician may start at an 8 mm device, followed by one or more 7 mm devices, followed by one or more 6 mm devices, and so on.

As discussed above, the device 100 may include ninitine or other materials that tend to have a highly predictable shape when in a relaxed or released position. Thus, in contrast to a coil that does not achieve a highly predictable shape (thereby, its relaxed state is highly arbitrary), an embodiment of the apparatus 100 may be a device that is specifically shaped in a target area of a particular shape or size So that the doctor can advantageously provide it. This customized treatment can improve patient outcomes.

The devices and methods disclosed herein are not limited to the deployment and use of medical devices within the vascular system and may include any number of different treatment applications. Other treatment sites may include areas or zones of the body that include any hollow anatomy.

Although the detailed description includes a number of specific matters, they should not be construed as limiting the scope of the present technology, but merely as exemplifying aspects of the technology and various embodiments of the present invention. It should be appreciated that the scope of the technology of the present invention encompasses other embodiments not described above. Various other changes, modifications and variations can be made in the arrangement, operation and details of the apparatus and method of the present technology disclosed herein without departing from the scope of the present invention. Unless otherwise stated, a reference to a singular element is not intended to mean "one and only one ", but rather to mean" one or more " In addition, it is not necessary that one apparatus and method solve all the problems (or possess all the advantages that can be achieved) that can be solved by the various embodiments of the disclosure contained within the scope of this disclosure. The use of "can" and its derivatives in the present specification should be understood as "possibly" or "selectively"

Claims (15)

An occlusion device for occluding a target area,
Comprising a elongate member,
The elongate member has opposing first and second side edges extending longitudinally along the member,
Said member comprising: (i) a folded structure in which first and second side edges are curled toward each other about a longitudinal axis of said member, (ii) said member forming a series of loops, The closure device has an expanded structure that is curled so that the edges are spaced apart from each other. The closure device of claim 1, wherein the first and second side edges are curled away to be spaced apart from each other by no more than twice the width of the member. 3. The closure device according to claim 2, wherein the first and second side edges are curled away from each other with a substantially member width. The closure device according to claim 1, wherein the elongate member comprises a shape memory material. The closure device of claim 1, wherein the elongate member comprises a flattened tubular member. The closure device of claim 1, wherein the member comprises a plurality of filaments. 7. The closure device according to claim 6, wherein the member is configured such that the filament forms a flat member. 2. The closure device according to claim 1, wherein the elongate member comprises at least one slit. 9. The closure device of claim 8 wherein at least one slit extends along a longitudinal axis of the member. 9. The closure device of claim 8, wherein the elongate member includes a plurality of slits extending along a longitudinal axis of the member and spaced apart in a substantially linear configuration. The closure device of claim 1, wherein the first and second side edges comprise a plurality of wing elements extending laterally therefrom. 12. An occlusion device according to claim 11, wherein the wing element extends from opposite sides of the elongate member. 13. The closure device of claim 12, wherein the pair of wing elements extend from opposite sides in a first longitudinal position along the member. 13. The apparatus of claim 12, wherein the wing element comprises a first and a second set of wing elements, the first set extending from the first side of the member and the second set extending from a longitudinal position different from the first set And extends from a second side of the member. A closure device for occluding a target area,
Comprising a elongate member comprising a plurality of filaments,
The member having a central backbone and a plurality of wing elements extending from the backbone,
Wherein the member has a folded structure in which (i) the wing is curled toward the backbone about a longitudinal axis of the member, and (ii) the backbone has an extended structure forming a series of loops.

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